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Update: Alabama Legislature Moves to Shield IVF from “Personhood” Ruling

In response to the recent turmoil caused by the Alabama Supreme Court’s February 16th ruling in LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine...more

In Alabama, Pre-Embryos are “Extrauterine Children” Under the State’s Wrongful Death Statute

On February 16, 2024, the Alabama Supreme Court issued an opinion in the consolidated cases LePage et al., v. The Center for Reproductive Medicine et al. and Burdick-Aysenne et al., v. The Center for Reproductive Medicine et...more

White House Executive Order on Artificial Intelligence: Implications for the Health Care and Life Sciences Industries

On October 30, 2023, President Joe Biden signed the first ever Executive Order (EO) that specifically directs federal agencies on the use and regulation of Artificial Intelligence (AI). A Fact Sheet for this EO is also...more

FDA Oversight of AI Software Developed by Health Care Providers

Introduction - Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is...more

[Virtual Briefing] Achieving Legal Compliance in AI: Minimizing Bias in Algorithms - June 29th, 1:00 pm - 3:30 pm ET

We’ve all heard troubling stories involving emerging tools powered by artificial intelligence (AI), in which algorithms yield unintended, biased, or erroneous results. Here are a few examples: - A monitoring tool for...more

CMS Launches First Federal Regulatory Action to Implement Medicare Drug Price Negotiation Program

On January 23, 2023, CMS published in the Federal Register its first proposed rulemaking to implement the Medicare Drug Price Negotiation Program (the “Negotiation Program”), which is included in the Inflation Reduction Act...more

Podcast: The PACE Program - What Changes May Be Coming Soon? - Diagnosing Health Care [Video]

Changes are on the horizon for provisions of the Program of All-Inclusive Care for the Elderly (PACE) that haven’t been updated in over a decade. What exactly is PACE and how will new proposed rule modifications affect PACE...more

2/2/2023  /  Healthcare , PACE , Proposed Rules

Video: Health Care's Past, Present, and Future - Diagnosing Health Care Podcast [Video]

In celebration of the 50th episode of our Diagnosing Health Care podcast, we’re looking at how the past 50 years of health law will impact health care in the next 50 years. On this episode, Epstein Becker Green attorneys...more

District Court Upholds Medicare Beneficiary’s Challenge to Local Coverage Determination

A recent decision by the U.S. District Court for the District of Columbia has clarified that a Medicare beneficiary may challenge a Medicare Local Coverage Determination (LCD) without first having to exhaust the lengthy...more

CMS Framework for Health Equity: An Opportunity for Client Advocacy

The Centers for Medicare & Medicaid Services (CMS) Office of Minority Health has published its comprehensive CMS Framework for Health Equity 2022–2032 (Framework). CMS’s Framework arose in response to the Biden...more

The No Surprises Act: New and Surprising Challenges for Clinical Laboratories

On July 13, 2021, the U.S. Departments of Health and Human Services, Labor, and the Treasury, and the Office of Personnel Management (collectively, “Departments”) published their highly anticipated interim final rule (“First...more

The No Surprises Act: A Look at the First Round of Federal Regulations on Surprise Billing

On July 13, 2021, the Biden administration (“Administration”) officially published the “Requirements Related to Surprise Billing; Part I”—its first regulatory response to the enactment of the No Surprises Act (“NSA”)—as an...more

On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast [Video]

This Diagnosing Health Care episode dives into the prospects of coverage expansion following the 2020 elections and also examines three major health care policy reform issues that have bipartisan support and could see...more

7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 2020

Based on their extensive experience advising health care industry clients, Epstein Becker Green attorneys and strategic advisors from EBG Advisors are predicting the “hot” health care sectors for investment, growth, and...more

HHS Releases Far-Reaching Proposed Rule to Prohibit Discrimination by “Covered Entities” Pursuant to Section 1557 of the...

On September 8, 2015, the U.S. Department of Health and Human Services (“HHS”) published a proposed rule titled “Nondiscrimination in Health Programs and Activities” (“Proposed Rule”)[1] to implement the nondiscrimination...more

New Value-Based Insurance Design Model for Medicare Advantage Plans Is the First of Multiple Medicare Plan Innovations Anticipated...

On September 1, 2015, the Centers for Medicare & Medicaid Services (“CMS”) announced[1] the opportunity for plan sponsors to test value-based insurance design (“VBID”) in the Medicare Advantage (“MA”) market. VBID refers to...more

CMS Issues Broad-Reaching Proposals to Better Align Medicaid Managed Care with the Commercial and Medicare Markets

On May 26, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule (“Proposed Rule”) containing the first proposed revisions to the Medicaid managed care (“MMC”) program’s regulations in more than...more

Mental Health Parity Requirements and Medicaid Plans: CMS Seeks Comment on Proposed Rule

On April 10, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a proposed rule (“Proposed Rule”) implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction...more

CMS Releases Updates to Its Medicare Advantage and Part D Plan Audit Protocols and Processes

On February 12, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released an updated version of its Medicare Advantage (“MA”) and prescription drug benefit (“Part D”) plan audit protocols and also announced the...more

CMS Requests Input on Health Plan Innovation Initiatives

Medicare Advantage (“MA”) plans, prescription drug plans (“PDPs”), and other stakeholders have until November 3, 2014, to provide input into the Centers for Medicare & Medicaid Services’ (“CMS’s”) consideration of potential...more

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more

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